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Onconova Therapeutics Promotes Dr. Steven M. Fruchtman to Chief Executive Officer

On January 15, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported the appointment of Dr. Steven Fruchtman as Chief Executive Officer and a member of the Board of Directors, effective immediately (Press release, Onconova, JAN 15, 2019, View Source [SID1234532665]). Dr. Fruchtman has served as President of Onconova since June 2018, and originally joined the Company in January 2015 as Chief Medical Officer. Previously, he held senior leadership positions in pharmaceutical and biotechnology companies and academia. Dr. Fruchtman is a board certified hematologist, who specialized in bone marrow diseases and stem cell transplantation. Dr Fruchtman replaces Dr. Ramesh Kumar, who will transition to an advisory role for the Company.

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"Steve is the right leader for Onconova at this time. He has been instrumental to the Company’s progress thus far and his proven track record in drug development will continue to serve the Company well as it advances the Phase 3-stage rigosertib programs toward approval and commercialization. The Board thanks Ramesh for his leadership and contributions to Onconova, and for positioning Onconova to reach critical upcoming milestones. We view Steve, and the recently expanded executive team that he has assembled, as poised to achieve clinical progress and business development objectives," said Michael Hoffman, Chairman of the Onconova Board of Directors.

Dr. Fruchtman has extensive industry experience in clinical research in MDS, hematologic malignancies, and solid tumors. He served with increasing leadership responsibilities at Ortho Biotech, Novartis, and biotechnology companies leading to successful clinical trial completion and regulatory approvals for a number of new chemical entities in various malignancies. Prior to his transition to industry, Steve served as the Director of the Myeloproliferative Disorder Program at The Mount Sinai Hospital in New York City, a Center of Excellence, and established the Stem Cell Transplant Program there. His commitment to the areas of hematology/oncology and myeloproliferative disorders is exemplified by his service as an external reviewer for prestigious journals such as the New England Journal of Medicine, Mayo Clinic Proceedings, Experimental Hematology, and others. He received his Bachelor of Arts with Honors from Cornell University, and his M.D. from New York Medical College. He was recently named to the Board of The Bone Marrow Foundation. Dr. Fruchtman commented, "I am very grateful to the Board for this honor. I thank Ramesh for his mentorship during my tenure as President and Chief Medical Officer. My colleagues at Onconova and I are focused on achieving our milestones. The global INSPIRE trial for rigosertib in MDS has the potential to offer a novel treatment option for these patients. We are very excited about the anticipated full enrollment of the INSPIRE trial in the second half of 2019, the advancement to Phase 3 of the oral rigosertib combination trial, and the studies of rigosertib in pediatric RASopathies and other unmet medical needs. I firmly believe that rigosertib has the potential to support multiple indications in different areas of oncology. In addition, our innovative CDK 4/6 inhibitor, ON 123300, is in advanced pre-IND stage, and is expected to enter the clinic during the first half of the year. This vision presents opportunities to enhance the value of the Company in the coming years."

Moleculin Biotech, Inc. Investor Presentation dated January 14, 2019

On January 15, 2019 Moleculin Biotech, Inc presented the corporate presentation (Press release, Moleculin, JAN 15, 2019, View Source [SID1234532663]).

Stemline Therapeutics Announces Upsizing and Pricing of $80 Million Public Offering of Common Stock

On January 15, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the pricing of an underwritten public offering of 8,888,889 shares of its common stock at a price of $9.00 per share, with expected gross proceeds to Stemline of $80 million (Press release, Stemline Therapeutics, JAN 15, 2019, View Source [SID1234532662]). Due to demand, this offering was upsized from the previously announced 6,600,000 shares. Stemline has also granted the underwriters a 30-day option to purchase up to 1,333,333 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on January 18, 2019, subject to customary closing conditions.

J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC are acting as co-lead managers and Roth Capital Partners, LLC, ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, National Securities Corporation, and Aegis Capital Corp. are acting as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL‑401) including clinical trials for additional indications including CMML, MF and other diseases; (ii) clinical development of SL‑801, SL‑701 and potentially SL-901; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.

Stemline has filed a preliminary prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-219794) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The preliminary prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other CD123 positive diseases.

Mirati Therapeutics Announces Dosing Of First Patient In Phase 1/2 Clinical Trial Of MRTX849, A Novel KRAS G12C Inhibitor

On January 15, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that it has dosed the first patient in a Phase 1/2 clinical trial of MRTX849, an investigational KRAS G12C inhibitor for patients with advanced solid tumors that harbor KRAS G12C mutations (Press release, Mirati, JAN 15, 2019, View Source [SID1234532661]).

"Today we have achieved an important milestone in the battle against cancers driven by KRAS mutations, one of the most common and difficult to treat patient populations. MRTX849 has been designed to specifically target KRAS G12C mutations, which are thought to be responsible for at least 14% of non-small cell lung adenocarcinoma, 4% of colorectal cancer, and subsets of other types of cancers," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "In preclinical studies MRTX849 potently and specifically bound to KRAS G12C and produced durable tumor regressions in patient-derived cancer models implanted in mice. Our Phase 1/2 clinical trial is designed to rapidly advance MRTX849 towards registration and approval."

"There are no approved targeted treatment options for patients with KRAS-driven cancers," said Pasi A. Jänne, M.D., Ph.D., Mirati Scientific Advisory Board Member, and Director of the Lowe Center for Thoracic Oncology at the Dana Farber Cancer Institute. "The development of a direct inhibitor of KRAS G12C is an important advancement in the field and this clinical study is designed to rapidly and efficiently evaluate the tolerability and efficacy of MRTX849 to treat patients with tumors driven by this mutation."

Mirati’s Phase 1/2 clinical trial will evaluate MRTX849 as a single agent in patients with advanced solid tumors that harbor KRAS G12C mutations. The Phase 1 dose escalation phase of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MRTX849 in patients with molecularly-identified KRAS G12C-positive advanced solid tumors. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose. Additional information can be found at View Source

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified KRAS G12C-positive advanced solid tumors

Illumina to Announce Fourth Quarter and Fiscal Year 2018 Financial Results on Tuesday, January 29, 2019

On January 15, 2019 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for fourth quarter and fiscal year 2018 following the close of market on Tuesday, January 29, 2019 (Press release, Illumina, JAN 15, 2019, View Source [SID1234532660]).

On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, January 29, 2019. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (800) 708-4539, or 1 (847) 619-6396 outside North America, both with passcode 47970793.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.